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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 065171


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NDA 065171 describes DEMECLOCYCLINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharm, Barr, Epic Pharma Llc, and Impax Labs, and is included in five NDAs. It is available from five suppliers. Additional details are available on the DEMECLOCYCLINE HYDROCHLORIDE profile page.

The generic ingredient in DEMECLOCYCLINE HYDROCHLORIDE is demeclocycline hydrochloride. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the demeclocycline hydrochloride profile page.
Summary for 065171
Tradename:DEMECLOCYCLINE HYDROCHLORIDE
Applicant:Barr
Ingredient:demeclocycline hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 065171

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength150MG
Approval Date:Dec 13, 2004TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG
Approval Date:Dec 13, 2004TE:RLD:No

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